Senior Process Engineer

Category:  Engineering
Location: 

Tianjin, Tianjin, CN

   

NOVO NORDISK

JOB DESCRIPTION 岗位说明书

Job Title 职位名称

Senior Process Engineer 高级工艺工程师

Area 业务区域

Durable Device 耐用器械部  

Dept. 部门

Process and Maintenance

Immediate Superior 直接主管 org. chart 组织架构图)  

 

                         

Process and Maintenance Manager

工艺与维修经理

 

Process Associate Manager

工艺副经理

 

Senior Process Engineer

高级工艺工程师

组织结构图

 

Qualifications (minimum requirements) 任职资格

Education Background: 教育背景

 

  • Bachelor Degree and above in manufacturing engineering or similar education background.     制造工程或相关学科领域大学本科及以上学历。
  • Education/training of GMP regulation, validation, LEAN and statistics is preferable.                    最好接受过GMP、验证、精益管理、统计的培训。
  • Fluent in written and reading English.                流利的英语听说技能。

 

 

 

Professional Experience专业经验:

 

  • Minim 7 years of relevant working experience.            至少7年相关工作经验。
  • Minim 5 years of experience in automation and mechanical areas.                                                  至少5年机械、自动化领工作经验。
  • Experience of working in a production environment with highly automated machines.                              在高度自动化设备生产环境的工作经验。
  • Knowledge and experience of GMP/ISO 9001/ISO 13485 regulated production, working with requirement for validation and change procedures.                      GMPISO9001ISO13485标准化要求的生产、验证、变更管理流程的知识和工作经验

 

         

 

 

Job content工作内容描述

Key areas of responsibility 主要工作职责:

Senior process engineer is responsible for compliance of daily production activities that to ensure quality and efficiency of production. Work according to GMP, GDP and SOP. Ensure NC, CR, PSE, QAP, validation, etc. are accomplished within schedule, and OEE, scrape rate are meet the KPI. 

高级工艺工程师的职责是保证日常生产活动合规,保证生产高质、高效。遵循GMPGDPSOP执行工作,确保NCCRPSEQAP、验证等工作按计划完成;确保OEE、废品率等KPI指标达标。

Main Job Tasks 主要工作任务:      

  • Be the process owner of appointed production machine/equipment. Accomplish all related job tasks on time.                                                                                                             担任指定生产设备的工艺负责人;按时完成所有相关工作任务。

 

  • Act as technical mentor of process area in projects and daily operations.                                    担任工艺领域项目和日常操作的技术指导:
    • Review the specification of new equipment and give input to technical owners. Work out URS/EMS and also includes clarification of documents towards suppliers.                                     检查新设备说明书,给技术负责人提供建议;做用户需求说明书、设备说明书、文件说明。 
    • Review validation documentation: AKK, FMEA, CRL, PCS, etc.                                       检查验证文件。
    • Coach the technical owner to test machines, including planning, FAT (at suppliers), SAT, IQ, OQ and support for PQ.                                                                                指导技术负责人测试机器设备及完成相关文件。
    • Address problems in a structured and standardised way and coach others in doing the same.       运用结构化和标准化的方法发现问题,并且推进该方法在工作中的实施。

 

  • Optimize existing production.                                                                               优化现有生产流程:
    • Continuously looking for improvement and be seen to think out of the box on manufacturing technologies.                                                                                      持续寻找改进点
    • Constantly ensure to decrease scrap from processes through implementation of Kaizen ideas and PIP projects.                                                                                       通过实施Kaizen改善建议和改善项目不断降低废品率
    • Implementation of changes that related to new tools to improve process, ergonomics, etc.          执行改进工艺的新工具等带来的变动
    • Handling of change requests (CR) in relation to changes.                                           处理CR
    • Drive changes and optimisations with limited support from senior management.                    在高级管理层的支持下推动改进和优化

 

  • Act as mentor of validation of equipment and processes.                                                    担任设备、工艺验证的导师:
    • Initiate validation training for process engineers.                          向工艺工程师提供验证培训
    • Train other employees to use eTIMS system for validation.                                         培训员工如何使用验证系统eTIMS
    • Responsible for the quality and compliance of validation documentation.                            对验证文件的质量和合规性负责
    • Feedback on status of validation to management.                                                   向管理层汇报验证工作状态

 

  • Do troubleshooting in relation to Non-conformities and production issues.                                   解决不符合和生产相关的问题:
    • Support root-cause investigation                                                                   支持根本原因调查
    • Take the responsibility for root-cause investigation if the root-cause is related to equipment.        当涉及设备相关的问题发生时,对根本原因调查负责
    • Implement changes necessary due to non-conformities.                                            执行因不符合产生的变动
    • Actively engage in solving deviations.                                                              解决偏差
    • Provide technical support for process engineers to deal with complex issues.                        对于复杂问题给工艺工程师提供支持
    • Provide technical recommendation to Senior Management.                                          向高级管理层提出技术建议

 

  • Create/review equipment and process documents.                                                          建立并检查工艺及设备文件:
    • Ensure that documents are translated and updated when new equipment is transferred to STJ.     保证及时翻译并更新设备的文件
    • Work out new documents if necessary.                                                            必要时撰写新文件
    • Coach and support others in working out new documents.                                          指导其他工程师撰写新文件
    • Cooperate with QS and QA in order to optimize documents.                                        QSQA部门合作优化文件
    • Review and give input to SOPs which related to equipment and process.                            检查设备和工艺相关标准操作流程文件并提出建议                 
  • Act as backup of all process owners and provide technical support.                                         担任所有工艺负责人的替代者,并提供技术支持:
    • Supervise the validation status of all equipment.                                                   管理所有设备的验证状态
    • Supervise the access control for equipment. Act as super user for all equipment to ensure all the accesses are given according to regulations.                                                       管理所有设备的使用权限,作为设备超级用户确保使用权限按照规定分配
    • Ensure all documents are always kept up to date.                                                  确保所有的权限都被及时更新
    • Coach new process owners.                                                                        指导新的工艺负责人
    • Provide technical support to all process engineers.                                                  向所有工艺工程师提供技术支持

 

  • Implement training programs for technicians and engineers to ensure best support in validation and technique.                                                                                                  培训工程师和技术员,以确保验证和技术支持:
    • Train new process engineers to ensure they have the competences like: validation, non-conformity handling, CR handling, ISO standard and GMP regulations regarding process area.                  培训新上岗工艺工程师,保证他们具备验证、NC处理、CR处理、ISO标准、GMP要求等工艺工作技能。
    • Train technicians and engineers to a higher technical skill and compliance level.                     培训工程师和技术员以提高技术水平和合规水平。

 

  • Responsible for standardization. Coordinate process team to execute FIT/MWD tasks, use SPS method to resolve problems.                                                                                           标准化工作:协调工艺团队执行FIT/MWD工作任务,用系统解决问题的方法解决问题。

 

  • Responsible for technical inspections to the department, including but not limited to FDA, Lloyds, SFDA, etc. ensure all related activities are in compliance with applicable regulatory and standards. Make correction for the findings from audit and follow up actions.                                                               负责技术检查,包括FDA, Lloyds, SFDA等,确保所有活动合规。对审计发现点采取纠正活动并跟踪执行情况。

 

  • Present process during audit and inspection.                                                                在审计和检查中介绍工艺流程:
    • Present own process during audit and inspection.                                                  在审计和检查中介绍自己负责的工艺流程。
    • Guide audit and inspection tour on shop floor.                                                     带领审计人员巡视车间。
    • Coordinate with department fulfil request of audit and inspection.                                   协调部门工作以达到审计要求。
    • Support other engineers to answer question during audit and inspection.                           在审计期间帮助工艺工程师回答审计官的问题。

 

  • Ensure global SOP&GMP requirements implementation in STJ.                                               保证总部SOPGMP相关文件在本地实施:
    • Act as or supporting local document owner to review key global SOP and GMP requirement to ensure compliance.                                                                                亲身担任或者帮助其他本地文件负责人阅读关键总部SOPGMP相关文件以确保合规。
    • Review and give inputs to process report.                                                          检查工艺报告并提出建议。
    • Do gap analysis for the SOP and report including DI.                                               SOP和报告的差异分析。

 

  • Coaching on compliance and train engineers on process knowledge.                                         指导和培训工艺工程师
    • Identify compliance gaps in responsible process.                                                   识别合规风险
    • Coach other engineers on compliance.                                                              指导工艺工程师合规工作
    • Share findings and new regulation requirements.                                                  分享审计发现点和新要求       

 

  • Give inputs on NC/CR and process improvement.                                                           针对工艺改进和NC/CR给出意见:
    • Review NC/CR.                                                                                    检查NC/CR
    • Coach others on how to write NC/CR.                                                              指导员工写NC/CR
    • Provide professional idea to continuous improvement projects.                                     在改进项目中提出专业意见
    • Share best practice across sites.                                                                   与其他工厂分享最佳实践方法

 

  • If take the role of site level SME, responsible for coordination of SME group. Drive knowledge sharing and process alignment. Present as site level SME for the cross area process.

如果是SME,要负责推动流程统一和知识分享。

 

Other individual assignments 其他工作任务:

  • Incorporate Novo Nordisk Way (NNW) into daily way of working                                             将诺和诺德之道(NNW)融入到日常工作中
  • Other work assigned by line manager.                                                                       直线经理安排的其他工作。
  • Keep line manager accurately informed of work status as well as any problems                              保证将工作状态和所有问题准确通知到直线经理

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.